Dataset Information

Effectiveness and Feasibility of Pharmacist-Driven Penicillin Allergy De-Labeling Pilot Program without Skin Testing or Oral Challenges.

ABSTRACT: Documented penicillin allergies have been associated with an increased risk of adverse outcomes. The goal of this project was to assess the effectiveness and feasibility of a pharmacist-led penicillin allergy "de-labeling" process that does not involve labor-intensive skin testing or direct oral challenges. Adult patients with penicillin allergies were identified and interviewed by an infectious diseases pharmacy resident during a 3-month pilot period. Using an evidence-based standardized checklist, the pharmacist determined if an allergy qualified for de-labeling. In total, 66 patients were interviewed during the pilot period. The average time spent was 5.2 min per patient interviewed. Twelve patients (18%) met the criteria for de-labeling and consented to the removal of the allergy. Four patients (6%) met the criteria but declined removal of the allergy. In brief, 58.3% of patients (7/12) who were de-labeled and 50% of patients (2/4) who declined de-labeling but had their allergy updated to reflect intolerance were subsequently prescribed beta-lactam antibiotics and all (9/9, 100%) were able to tolerate these agents. A pharmacist-led penicillin allergy de-labeling process utilizing a standardized checklist is an effective and feasible method for removing penicillin allergies in patients without a true allergy.

SUBMITTER: Song YC

PROVIDER: S-EPMC8293328 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature

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Effectiveness and Feasibility of Pharmacist-Driven Penicillin Allergy De-Labeling Pilot Program without Skin Testing or Oral Challenges.

Song You-Chan YC Nelson Zachary J ZJ Wankum Michael A MA Gens Krista D KD

Pharmacy (Basel, Switzerland) 20210720 3

Documented penicillin allergies have been associated with an increased risk of adverse outcomes. The goal of this project was to assess the effectiveness and feasibility of a pharmacist-led penicillin allergy "de-labeling" process that does not involve labor-intensive skin testing or direct oral challenges. Adult patients with penicillin allergies were identified and interviewed by an infectious diseases pharmacy resident during a 3-month pilot period. Using an evidence-based standardized checkl ...[more]

PMID: 34287342

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Project description:ImportancePenicillin allergies are frequently mislabeled, which may contribute to use of less-preferred alternative antibiotics.ObjectiveTo evaluate a pharmacist-led allergy assessment program's association with antimicrobial use and clinical outcomes.Design, setting, and participantsA pharmacist-led allergy assessment program was launched in 2 phases (June 1, 2015, and November 2, 2016) at a single-center tertiary referral hospital. The longitudinal cross-sectional study included all study period adult admissions; hospitalwide outcomes were assessed by segmented regression. Individual outcomes were assessed within an embedded propensity score-matched case-control study of inpatients undergoing comprehensive allergy assessment following self-report of penicillin allergy. Analysis occurred from March 1, 2020, to February 29, 2020.ExposuresThe longitudinal study analyzed hospital-level outcomes over 3 periods: preintervention (15 months), phase 1 (structured allergy history alone, 16 months), and phase 2 (comprehensive assessment including penicillin skin testing, 52 months). The case-control study defined cases as individuals undergoing comprehensive allergy assessment.Main outcomes and measuresHospital-level outcomes included antibiotic days of therapy per 1000 patient-days and hospital-acquired Clostridioides difficile infection (CDI) incidence per 10 000 patient-days. Individual outcomes included antibiotic selection, overall survival, and CDI-free survival.ResultsLongitudinal analysis spanned 2014-2020 (median admissions, 46 416 per year; interquartile range [IQR], 46 001-50 091 per year). Hospitalwide, allergy histories were temporally associated with decreased use of nonpenicillin alternative antibiotics (rate ratio, 0.87; 95% CI, 0.79-0.97) and high-CDI-risk antibiotics (rate ratio, 0.91; 95% CI, 0.85-0.98). Penicillin skin testing was temporally associated with lower hospital-acquired CDI rates (rate ratio, 0.61; 95% CI, 0.43-0.86). The embedded case-control study included 272 cases and 819 controls. Median age was 63 years (interquartile range, 51-73 years), 553 (50.7%) patients were women, and 229 (21.0%) patients were Black. Allergy-assessed patients were less likely to receive high-CDI-risk antibiotics at discharge (odds ratio, 0.66; 95% CI, 0.44-0.98). Estimated reductions in mortality (hazard ratio, 0.77; 95% CI, 0.55-1.07) and hospital-acquired CDI risk (hazard ratio, 0.53; 95% CI, 0.18-1.55) were not statistically significant.Conclusions and relevancePharmacist-led allergy assessments may be associated with reduced high-CDI-risk antibiotic use at both hospitalwide and individual levels. Although individual reductions in mortality and CDI risk did not achieve significance, divergence of survival curves suggest longer-term benefits of allergy delabeling warrant future study.

Project description:BackgroundPenicillin allergy is the most commonly reported drug allergy in the US. Despite evidence demonstrating that up to 90% of labels are incorrect, scalable interventions are not well established. As part of a larger mixed methods investigation, we conducted a qualitative study to describe the barriers to implementing a risk-based penicillin de-labeling protocol within a single site Veteran's hospital.MethodsWe conducted individual and group interviews with multidisciplinary inpatient and outpatient healthcare teams. The interview guides were developed using the Theoretical Domains Framework (TDF) to explore workflows and contextual factors influencing identification and evaluation of patients with penicillin allergy. Three researchers iteratively developed the codebook based on TDF domains and coded the data using thematic analysis.ResultsWe interviewed 20 clinicians. Participants included three hospitalists, five inpatient pharmacists, one infectious disease physician, two anti-microbial stewardship pharmacists, four primary care providers, two outpatient pharmacists, two resident physicians, and a nurse case manager for the allergy service. The factors that contributed to barriers to penicillin allergy evaluation and de-labeling were classified under six TDF domains; knowledge, skills, beliefs about capabilities, beliefs about consequences, professional role and identity, and environmental context and resources. Participants from all groups acknowledged the importance of penicillin de-labeling. However, they lacked confidence in their skills to perform the necessary evaluations, such as test dose challenges. The fear of inducing an allergic reaction and adding further complexity to patient care exacerbated their reluctance to de-label patients. The lack of ownership of de-labeling initiative was another significant obstacle in establishing consistent clinical workflows. Additionally, heavy workloads, competing priorities, and ease of access to alternative antibiotics prevented the prioritization of tasks related to de-labeling. Space limitations and nursing staff shortages added to challenges in outpatient settings.ConclusionOur findings demonstrated that barriers to penicillin allergy de-labeling fall under multiple behavioral domains. Better role clarification, opportunities to develop necessary skills, and dedicated resources are needed to overcome these barriers. Future interventions will need to employ a systemic approach that addresses each of the behavioral domains influencing penicillin allergy de-labeling with stakeholder engagement of the inpatient and outpatient health care teams.

Dataset Information

Effectiveness and Feasibility of Pharmacist-Driven Penicillin Allergy De-Labeling Pilot Program without Skin Testing or Oral Challenges.

Publications

Effectiveness and Feasibility of Pharmacist-Driven Penicillin Allergy De-Labeling Pilot Program without Skin Testing or Oral Challenges.

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